LONDON (ShareCast) - (Sharecast News) - Hutchmed China said in an update on Wednesday that it has completed patient enrollment for its global phase three 'Saffron' trial evaluating the combination of Orpathys and Tagrisso in certain lung cancer patients with MET overexpression or amplification who had progressed following Tagrisso treatment.
The AIM-traded firm said the last patient was randomised on 31 October, with topline results expected in the first half of 2026.

It said the study was assessing the efficacy and safety of the Orpathys and Tagrisso combination versus platinum-based doublet chemotherapy in patients with EGFR-mutated, MET-overexpressed or amplified, locally advanced or metastatic non-small cell lung cancer.

A total of 338 patients were enrolled across more than 230 sites in 29 countries.

The primary endpoint was progression-free survival as assessed by independent central review, with additional endpoints including overall survival, response rate, and safety.

Hutchmed said the combination offered a promising all-oral, chemotherapy-free treatment option for patients with disease progression on an EGFR tyrosine kinase inhibitor.

The therapy was approved in China in June based on results from the 'Sachi' phase three study, which showed significant clinical benefit in this patient population.

Orpathys, developed jointly by AstraZeneca and Hutchmed, is a selective MET inhibitor marketed by AstraZeneca, while Tagrisso is AstraZeneca's third-generation EGFR inhibitor.

The company said results from Saffron could support regulatory submissions in the US and other global markets.

"This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor, and was granted approval in China in June based on the results of the Sachi randomised phase three trial," Hutchmed said in its statement.

The company said Saffron formed part of a broader global development programme exploring Orpathys and Tagrisso combinations in patients with EGFR-mutated non-small cell lung cancer.

It said the partners were also conducting the 'Sanovo' and 'Sachi' trials in China, both evaluating the same combination in different patient settings, following encouraging data from earlier 'Tatton' and 'Savannah' studies that demonstrated high and durable response rates.

Hutchmed said the Saffron study received fast track designation from the US Food and Drug Administration, and remained a key component of its global registration strategy for the Orpathys and Tagrisso combination.

At 1259 GMT, shares in Hutchmed China were up 0.85% at 236p.

Reporting by Josh White for Sharecast.com.

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